1. Field of the Invention
The present invention relates to enteral feeding, and more particularly to a gastrojejunal feeding system. More specifically, the present invention relates to a jejunal adapter having a low profile configuration which permits venting of gas from the stomach while simultaneously providing fluid directly to the jejunum of a patient.
2. Prior Art
Enteral feeding is frequently used to assist patients who are ambulatory and/or in a combative state and require some sort of alternative feeding device to receive nutrition when unable to take nutrition orally. Typically, the patient is fed though a tube connected to a source of nutrition which is directed into a digestive organ of the patient through a feeding device. As used herein, the term feeding shall be interpreted to include nutritional feeding, medicating or hydrating.
Over the years a variety of feeding devices have been utilized. For instance, nasogastric or nasoenteric feeding devices have been used which direct a feeding tube into a patient""s nose, through the nasal passage, down the esophagus and into either the stomach (nasogastric) or the small intestine (nasoenteric) of the patient. Both feeding devices operate satisfactorily to feed a patient by use of a relatively noninvasive procedure; however, each device also has several drawbacks. For instance, as the feeding tube is passed through the patient""s nasal passage, it may become misdirected into the pulmonary tree which could result in discomfort or even harm to the patient, particularly if fluids are unintentionally administered through the feeding tube and into the pulmonary tree. Additionally, feeding tubes passed through the nasal passage may also result in local irritation, epistaxis, sinusitis, or various other complications to the patient.
In an attempt to advance the art of nasogastric and nasoenteric devices, lighter, smaller feeding tubes have been used to reduce irritation of the nasal passage. Although reducing discomfort, these type of feeding tubes were prone to kinking or clogging. Because of the above-noted deficiencies, nasal entry methods were typically used in short term applications for no longer than thirty days.
Since nasoenteric or nasogastric feeding devices were best suited for use in short term applications, a need existed for a device capable of long term deployment. A variety of surgical methods have been utilized such as a Stamms surgical gastrostomy in which the anterior gastric wall was lifted with a pair of guy sutures while the surgeon cut through the serosa and the muscular wall of the stomach to form a gastrostomy. A catheter was then introduced through the gastrostomy and into the stomach. Although a surgical gastrostomy was better suited for long-term applications, it was substantially more invasive to the patient and typically required use of a general anesthetic. Finally, as with any surgical procedure, the opportunity for infection or morbidity was increased.
In an attempt to provide a less invasive procedure for long-term access to the stomach, several percutaneous endoscopic gastrostomy methods have been suggested which access the stomach by a needle or cannula forced into the stomach. Generally, a percutaneous endoscopic gastrostomy (PEG) is performed in one of three methods: the pull technique, the push technique or the introducer technique.
In the pull technique, the gastrostomy tube was equipped with a wire loop through the proximal end of a catheter, while a cannula was slipped over the catheter so that a portion of the wire loop extended therefrom and a smooth transition from the wire loop to the cannula provided. A bolster or other similar stop member was attached at the distal end of the catheter and the gastrostomy tube was then deployed by an endoscopic procedure in which an endoscope was inserted down the patient""s esophagus and into the stomach. Thereafter, the subcutaneous tissue was incised below the skin and a needle and cannula arrangement thrust through the incision adjacent the abdominal and gastric walls. Once the cannula penetrated the stomach wall, the needle was removed and the cannula was snared by a loop which extended from the endoscope. The physician then passed a length of suture through the cannula and into the patient""s stomach. Once a sufficient length of the suture was directed into the patient""s stomach, the snare was loosened from the cannula and retightened about the suture. The endoscope could then be removed which drew the snare and suture out through the patient""s mouth. The gastrostomy tube was then tied to the suture extending from the patient""s mouth and pulled back through the mouth, down the esophagus, into the stomach, and out through the gastrostomy until the bolster securely abutted the stomach wall. Finally, a retaining ring was fitted about the gastrostomy tube adjacent the patient""s outer abdomen to secure the gastrostomy tube thereto.
Another method utilized to access the stomach was the push method. This method utilized an endoscope which was placed within the stomach through the patient""s mouth. The skin and subcutaneous tissue could then be incised and a needle passed through the incision and pierced through the abdominal and stomach walls. Once the needle pierced through the stomach wall, a guide wire was passed through the needle and a snare deployed from the endoscope to capture the guide wire. As the endoscope was removed back through the mouth of the patient, the snare and guide wire were also pulled along and out the patient""s mouth. As tension was maintained on the guide wire, a gastrostomy tube was pushed therealong until the proximal end of the gastrostomy tube extended outwardly from the gastrostomy. Once a portion of the gastrostomy tube extended from the gastrostomy, it was pulled the remainder of the distance outward until the bolster securely abutted the stomach wall. Finally, a retaining ring was fitted about the gastrostomy tube adjacent the patient""s abdomen.
Another well known percutaneous endoscopic gastrostomy method was the introducer technique which involved thrusting a needle through the skin and into the stomach of a patient. Once the needle pierced through the stomach wall, a guide wire was threaded along the needle into the stomach and an incision was made about the guide wire. Next, the introducer set, which included an outer sheath and an inner dilator, was passed over the wire and into the stomach in order to dilate the incision. The physician then removed the inner dilator and wire leaving the outer sheath behind. A physician utilizing this method would then insert a catheter through the outer sheath and into the stomach. Thereafter, the outer sheath was frangibly peeled away and withdrawn from the patient leaving the catheter in place.
Although each of the above-described percutaneous endoscopic gastrostomy methods provided a relatively less invasive method than other surgical procedures, even these methods had drawbacks. Percutaneous endoscopic gastrostomy tubes extended a substantial distance outwardly from the patient might be deemed cosmetically undesirable by the patient. Moreover, even though these gastrostomy tubes could be deployed for a substantially greater period of time, they typically had to be removed and replaced after about six months.
In order to further advance the art, a variety of replacement gastrostomy tubes have been suggested. One such replacement gastrostomy tube is disclosed in U.S. Pat. No. 4,798,592 to Parks entitled xe2x80x9cGastrostomy Feeding Devicexe2x80x9d which describes a gastrostomy tube having an inflatable balloon and an adjustable ring. The gastrostomy tube was inserted through a matured stoma formed through the patient""s stomach wall with the balloon in a deflated state. Once the distal end of the gastrostomy tube was properly positioned inside the patient""s stomach, the balloon was inflated and the adjustable ring seated against the patient""s outer abdomen so that the gastrostomy tube was secured in place.
Although the device disclosed by Parks provided a gastrostomy tube which could be inserted through a matured stoma of a patient, use of a gastrostomy tube with an inflated balloon proved too unreliable. An inflated balloon could become accidentally deflated which permitted inadvertent removal of the gastrostomy tube from the stoma. Patients were also known to experience discomfort when using such devices since the inflated balloon had an enlarged profile once expanded within the patient""s stomach. Just as with the percutaneous endoscopic gastrostomy tubes, these gastrostomy tubes extended outwardly a substantial length from the patient which might be perceived as cosmetically unappealing. Moreover, it was found that in certain patients fluid contained within a patient""s stomach could be unintentionally refluxed so that use of any of the above-mentioned gastrostomy tubes feeding directly into the stomach could present an unsafe or even life threatening situation.
Another advancement in the art to overcome some of the disadvantages of prior art gastrostomy tubes was the development of skin-level, or low profile, gastrostomy tube devices such as those disclosed in U.S. Pat. No. 5,248,302 to Patrick et al. entitled xe2x80x9cpercutaneous Obduratable Internal Anchoring Devicexe2x80x9d which is incorporated herein by reference. The Patrick et al. reference disclosed a gastrostomy tube comprising a tubular member having a deformable obduratable internal retention member at one end and an external retention member at the other end thereof for securing the tubular member inside the stomach. The internal retention member was designed to pass through a matured stoma of a patient and be elastically expanded outwardly in order to anchor the gastrostomy tube within the stomach. A plurality of flexible retaining arms with an orifice formed at the distal end thereof was provided at one end of a hollow tubular member, while an external retention member was provided at the other end of the tubular member. The external retention member included a body with an opening and a lumen formed therethrough with a pair of legs extending from the body adapted to abut the skin of the patient and prevent the tubular member from slipping completely through the matured stoma.
The above-described gastrostomy tube was deployed inside the patent""s stomach by inserting an obturator rod through the lumen of the tubular member until the rod registered against the orifice formed between the flexible retaining legs of the internal retention member. By pushing the obturator rod axially against the retaining arms, the arms mechanically elongated and slenderized to a size slightly less than the inner diameter of the tubular member lumen. Slenderization of the retaining arms allowed safe insertion or removal of the internal retention member into, or from, an established, matured stoma of a patient through the tubular member. After the internal retention member was inserted inside the stomach, the obturator rod was then withdrawn through the lumen of the tubular member which caused the flexible retaining arms of the internal retention member to assume their preset enlarged shape, thereby anchoring the internal retention member against the stomach wall. Once the internal retention member was properly anchored, a tube administration set was connected to the opening of the external retention member to establish fluid flow communication between the source of fluid and a patient""s stomach. In this way, fluid was provided to a patient through the gastrostomy tube.
Although such feeding devices provided a substantial improvement in the art by furnishing a low profile gastrostomy tube, even these devices could be further enhanced. Since gastrostomy tubes fed directly into the stomach of a patient, these devices were completely incapable of assisting patients prone to gastroesophageal reflux or aspiration caused by feeding fluid directly into the stomach. However, it was well known in the art that feeding fluid directly into the jejunal region of the small intestine of a patient, rather than into the stomach, drastically reduced the possibility for gastroesophageal reflux. Accordingly, several devices have been suggested which accessed the jejunum either directly by use of a jejunostomy or indirectly through a gastrojejunostomy wherein a feeding tube was inserted though a gastrostomy tube and passed through the pyloric sphincter and into the small intestine such that the distal end of the feeding tube terminated within the jejunum.
Another device typical of the art is described in U.S. Pat. No. 5,851,195 to Gill entitled xe2x80x9cDirect Percutaneous Endoscopic Jejunostomy Method and Apparatusxe2x80x9d. The Gill device included a wire with a proximal end having a bend and a distal end having a piercing tip with a sheath which movably surrounds the piercing tip. The sheath and wire are deployed by use of an endoscope that passed the wire down the esophagus, through the pyloric sphincter and into the jejunum of the patient. The wire was then slid relative to the sheath so that it was emergent therefrom and driven through the abdominal walls. A percutaneous access tube was then attached to the proximal end of the wire. Once the percutaneous access tube was properly attached, the wire was pulled from its distal end in order to drag a portion of the access tube into the jejunum while a portion of the access tube extended a substantial length outwardly away from the patient for connection to a tube administration set.
Devices constructed in accordance with the teachings of Gill operated effectively to provide access to the jejunum while preventing gastroesophogeal reflux; yet, these devices had many of the same drawbacks found with the previous percutaneous endoscopic gastrostomy tubes. For instance, these devices had a tube which extended outwardly a substantial distance from the patient. Further, since devices in accordance with Gill had a single tube in communication solely with the jejunum, these devices were incapable of venting gases from the stomach while simultaneously feeding fluid directly to the jejunum.
Therefore, there appears to be a need in the art for a low profile jejunal feeding device. It would also be desirable to have a low profile jejunal feeding device which includes an adapter attachable to prior art low profile gastrostomy tubes. It would be further desirable to provide a low profile jejunal feeding device which allows for venting of air from the stomach while simultaneously providing fluid directly into the jejunum of a patient.
In brief summary, the present invention overcomes and substantially alleviates the deficiencies in the prior art by providing a low profile jejunal adapter for converting a low profile gastrostomy tube into a gastojejunostomy tube. The low profile jejunal adapter is configured to be used with a prior art low profile gastrostomy tube having a hollow tubular member with an external retention member attached at one end and an internal retention member attached at the other end for securing the tubular member within the stoma of a patient.
The external retention member comprises a body having a lumen formed therethrough and opposed legs which are adapted to abut the outer abdomen of a patient. Preferably, the internal retention mechanism comprises a plurality of flexible retaining arms with an orifice formed through the distal end thereof. The flexible retaining arms are releasably expandable within a patient""s stomach using an obturator rod to insert and anchor internal retention member within a patient""s stomach.
Alternatively, the internal retention member can have an inflatable balloon retention mechanism instead of flexible retaining arms which also anchors the low profile gastrostomy tube inside the patient""s stomach. The balloon retention mechanism includes an inflatable balloon with a lumen which extends axially along the low profile gastrostomy tube and communicates with a one way valve. To inflate the balloon, the user engages a syringe or other suitable device and injects air through the one-way valve which inflates the balloon.
The low profile jejunal adapter of the present invention includes a body having opposing upper and lower surfaces and opposing forward and rearward portions. The body also includes a protrusion extending axially from the lower surface thereof with a primary lumen formed therethrough in communication with a channel also formed through the body. Further, the channel is longitudinally formed along the upper surface of the body having an arcuate shape which interconnects the primary lumen to the primary port. Extending from the primary port is a primary tubular extension which has a threaded cap attached to its free end. The protrusion is sized and shaped to be engageable within the opening of the external retention member such that the low profile jejunal adapter is securely engaged with the low profile gastrostomy tube.
The low profile jejunal adapter also includes a feeding tube for transporting fluid to the jejunum of the patient. The feeding tube is sized and shaped to be inserted through the pathway formed through the primary tubular extension, the channel and the primary lumen of the jejunal adapter as well as the low profile gastrostomy tube. The feeding tube includes a plurality of radial apertures formed proximate the distal end thereof to ensure proper fluid flow out of the feeding tube and into the jejunum. In addition, the feeding tube may also be adapted to include a plurality of weights located at the distal end thereof to assist in maintaining the distal end of the feeding tube within the jejunum or a coiled end to achieve the same result.
Once the distal end of the feeding tube is properly positioned within the jejunum, the proximal end of the feeding tube is threaded through the primary lumen along the channel and out the primary tubular extension such that the feeding tube extends approximately parallel relative to the abdomen of the patient, thereby presenting a substantially low profile relative to the patient. Once the distal end of the feeding tube is properly positioned within the jejunum of the patient, the proximal end of the feeding tube may then be cut to any desirable length and connected to a tube administration set using an adapter. The tube administration set is in turn connected to a fluid source.
Aside from the primary lumen, the low profile jejunal adapter further comprises a venting lumen formed axially through the protrusion having a generally banana-shaped configuration which permits the jejunal adapter to vent air from the stomach through the low profile gastrostomy tube and out the jejunal adapter, while simultaneously feeding fluid to the jejunum through the feeding tube. The venting lumen is in communication with a venting port formed at the rearward portion of the body. A venting tubular extension is connected to the venting port with a cap attached thereto for sealing the venting tubular extension during non-use.
Another unique aspect of the low profile jejunal adapter is that it includes a mechanism for latching and securing the jejunal adapter to a low profile gastrostomy tube inserted through a stoma of a patient. The latching mechanism includes a leg extending from the lower surface of the body with a finger formed at a distal end thereof. The leg functions to space the finger a distance from the body of the low profile jejunal adapter so that one of the legs of the external retention member may be securely nested between the lower surface and finger of the jejunal adapter.
The low profile of the jejunal adapter also includes a gastrostomy cap retention mechanism for retaining the tethered cap of the low profile gastrostomy tube. The gastrostomy cap retention mechanism comprises a depression formed in the upper surface of the body with a U-shaped groove formed in the forward portion of the upper surface, while a U-shaped undercut is located below and aligned with the U-shaped groove. The depression and U-shaped groove are sized and shaped to receive the cap, and shaft of the cap, respectively. Finally, the U-shaped undercut is adapted to receive the plug portion of the cap. Once properly nested therein, the cap is releasably retained by the cap retention mechanism.
An alternative embodiment of the low profile jejunal adapter is also contemplated and provides a jejunal adapter with enhanced cost effectiveness. The alternative embodiment of the low profile jejunal adapter comprises a body having an opposing upper and lower surfaces and opposing forward and rearward portions. The body comprises a protrusion axially extending from the lower surface with a primary lumen formed therethrough and a primary port formed through the body in communication with the primary lumen. The protrusion is sized and shaped to be receivable within the lumen of the external retention member of the low profile gastrostomy tube. A hole is formed through the upper surface which is aligned with the primary lumen for receipt of a stylet, or guide wire, to assist in directing a feeding tube into the jejunum. The body of the jejunal adapter also includes a pair of slots formed therethrough for returning a plate.
The plate is sized to be fitted over the upper surface of the body and has a pair of tabs adapted to be receivable within the pair of slots formed at the upper surface to secure the plate to the body once tabs are engaged within the slots. The plate further includes a plug member which is sized and shaped to seal the hole of the upper surface once the plate is secured to the body. The low profile jejunal adapter of the alternate embodiment also includes a feeding tube which is inserted through the primary lumen of the jejunal adapter for providing fluid to the jejunum.
Similar to the preferred embodiment, the alternative embodiment also includes a venting lumen formed through the protrusion of the body having a generally banana shaped cross-section which allows for venting of air from the stomach. The venting lumen is in communication with a venting port formed at the rearward portion of the body with a venting tubular extension which extends outwardly from the venting port and is oriented generally perpendicular relative to the venting lumen.
Another distinguishing feature of the alternative embodiment from the preferred embodiment is that the feeding tube is fixedly attached to the primary lumen of the low profile jejunal adapter. Since the distance to a patient""s jejunum may vary from patient to patient depending on age or build, various low profile jejunal adapters are manufactured having feeding tubes with differing lengths to accommodate patients of different sizes.
Accordingly, the primary object of the present invention is to provide a jejunal feeding adapter which is adapted to be attachable to a low profile gastrostomy tube and is similarly configured to have a low profile orientation relative to a patient.
Another object of the present invention is to provide a low profile jejunal adapter which allows for venting of air from the stomach while simultaneously feeding fluid to the jejunum of a patient.
It is yet another object of the present invention to have a low profile jejunal adapter which can accommodate patients of various ages and differing builds.
These and other objects of the present invention are realized in the preferred embodiment of the present invention, described by way of example and not by way of limitation, which provides for a low profile jejunal feeding adapter having a low profile configuration which is attached to a low profile gastrostomy tube.
Additional objects, advantages and novel features of the invention will be set forth in the description which follows, and will become apparent to those skilled in the art upon examination of the following more detailed description and drawings in which like elements of the invention are similarly numbered throughout.